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Guidance

Note:  Posted Guidance documents on this website do not represent an all inclusive list. Not all current guidance documents are posted online as many are currently under revision. Please call the Office of the IRB at 210-567-2351 with any questions concerning current guidance.

Instructions:

Always return to this webpage to create new submissions to ensure you are using the most current Guidance.

How to Register for CITI (Video Tutorial-with audio)
Instructions on changing CITI Learner Group
Informed Consent Document Guidelines
Checklist for Elements of Informed Consent
Checklist for Elements of an Information Sheet
Guidelines for Advertising for Research Subjects
Guidance on Observation of the Consenting Process
FDA Guidance on Study of Gender Differences in the Clinical Evaluation of Drugs
FDA Guidance for Industry: Establishing Pregnancy Exposure Registries
Existing Specimens -Guidelines for IRB Applications Involving the Use of Existing Specimens
Checklist for Final IRB-1 (Full Board Review) Submission
Waivers and Alterations Guidance
IRB Guidance on Data and Safety Monitoring Plan
IRB Guidance on Reporting Emergency Use of HUD to Sponsor/IRB
Accounting for Disclosures Under HIPAA For Research
Assurance Letter
IRB Guidance on Surrogate Consent - DECISION TREE: ADULTS AND EMANCIPATED MINORS NON-VA STUDIES
IRB Guidance on Surrogate Consent - DECISION TREE: ADULTS AND EMANCIPATED MINORS, VA STUDIES
IRB Guidance on Surrogate Consent - DECISION TREE: MINORS (under age 18 and not emancipated)